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A Double-Blind Placebo-Controlled Trial of Granulocyte
Colony-Stimulating Factor in Elderly Patients With Previously Untreated
Acute Myeloid Leukemia: A Southwest Oncology Group Study (9031)
John E. Godwin,
Kenneth J. Kopecky,
David R. Head,
Cheryl L. Willman,
Catherine P. Leith,
Harry E. Hynes,
Stanley P. Balcerzak, and
Frederick R. Appelbaum
From the Loyola University Chicago, Maywood, IL; the Southwest
Oncology Group Statistical Center, Seattle, WA; St Jude Children's
Research Hospital, Memphis, TN; the University of New Mexico,
Albuquerque, NM; the Wichita CCOP, Wichita, KS; the Ohio State
University Health Center, Columbus, OH; and the Puget Sound Oncology
Consortium, Seattle, WA.
Older age is a poor prognosis factor in acute myeloid leukemia
(AML). This double-blind trial was designed to test the hypothesis that
granulocyte colony-stimulating factor (G-CSF) used as supportive care
could improve the treatment of elderly AML patients. Two hundred
thirty-four patients 55 or more years of age with a morphologic diagnosis of de novo or secondary AML, French-American-British (FAB)
M0-M7, excluding M3, were randomly
assigned to a standard induction regimen (daunorubicin at 45 mg/m2 intravenously [IV] on days 1 through 3 and Ara-C at
200 mg/m2 IV continuous infusion on days 1 through 7) plus
either placebo or G-CSF (400 µg/m2 IV over 30 minutes
once daily). Results are reported here for 211 centrally confirmed
cases of non-M3 AML. The two groups were well balanced in
demographic, clinical, and hematological parameters, with median ages
of 68 years in the G-CSF and 67 years in the placebo groups. The
complete response (CR) rate was not significantly better in the G-CSF
group: 50% in the placebo and 41% in the G-CSF group (one-tailed
P = .89). Median overall survival was also similar, 9 months
(95% confidence interval [CI], 7 to 10 months) in the placebo and 6 months (95% CI, 3 to 8 months) in the G-CSF arms (P = .71).
We found a significant 15% reduction in the time to neutrophil
recovery in the G-CSF group (P = .014). G-CSF had no impact
on recovery from thrombocytopenia (P = .80) or duration of
first hospitalization (P = .27). When infection complications were evaluated, G-CSF had a beneficial effect on the duration but not
on incidence of infection. G-CSF patients had fewer days with fever and
shorter duration of antibiotic use. However, there was no difference in
the frequency of total documented infections or in the number of fatal
infections (19% placebo v 20% G-CSF). In this study of
elderly AML patients, G-CSF improved clinical parameters of duration of
neutropenia and antibiotic use, but did not change CR rate or survival
or shorten hospitalization.
Blood, Vol. 91 No. 10 (May 15), 1998:
pp. 3607-3615
© 1998 by The American Society of Hematology.
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